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Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome

Primary Purpose

Obstructive Sleep Apnea, Sleep Hypopnea

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Armodafinil 150 mg/day
Placebo
Sponsored by
Cephalon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Excessive Sleepiness, Obstructive Sleep Apnea, Obstructive Sleep Hypopnea, nCPAP, Cephalon, Cephalon, Inc, Nuvigil

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Diagnosis and Criteria for Inclusion: Patients are included in the study if all of the following criteria are met: Written informed consent is obtained. The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive). The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy. The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria. The patient meets the following nCPAP therapy requirements: Adequate education and intervention efforts to encourage nCPAP therapy use must be documented. A patient's nCPAP therapy regimen must be stable for at least 4 weeks. nCPAP therapy is shown to be effective, with effectiveness defined as having an apnea hypopnea index (AHI) of 10 or less during nocturnal PSG, and, in the opinion of the investigator, nCPAP is effective therapy. Following demonstration of effectiveness, evidence of regular nCPAP usage must be shown during a 2 week evaluation period (ie, nCPAP usage for at least 4 hours/night on at least 70% of the nights). The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology. Women must be surgically sterile, 2 years postmenopausal, or, if of child bearing potential, using a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study. The patient has a Clinical Global Impression of Severity of Illness (CGI S) rating of 4 or more. The patient has an ESS score of 10 or more. The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness. The patient is able to complete self rating scales and computer based testing. The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol. Criteria for Exclusion: Patients are excluded from participating in this study if 1 or more of the following criteria are met: has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) has a probable diagnosis of a current sleep disorder other than OSAHS consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day used any prescription drugs disallowed by the protocol or clinically significant use of over the counter (OTC) drugs within 14 days before the second screening visit has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM IV) has a positive urine drug screen (UDS) has a clinically significant deviation from normal in the physical examination is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) has used an investigational drug within 1 month before the initial screening visit has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) has a known clinically significant drug sensitivity to stimulants or modafinil

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Armodafinil 150 mg/day

    Placebo

    Outcomes

    Primary Outcome Measures

    Maintenance of Wakefulness Test (MWT)
    The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).
    Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit.
    Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 10, 2004
    Last Updated
    July 12, 2013
    Sponsor
    Cephalon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00079677
    Brief Title
    Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
    Official Title
    A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 mg/Day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Cephalon

    4. Oversight

    5. Study Description

    Brief Summary
    The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea, Sleep Hypopnea
    Keywords
    Excessive Sleepiness, Obstructive Sleep Apnea, Obstructive Sleep Hypopnea, nCPAP, Cephalon, Cephalon, Inc, Nuvigil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    263 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Armodafinil 150 mg/day
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Armodafinil 150 mg/day
    Intervention Description
    Armodafinil 150 mg once daily in the morning
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo tablets once daily
    Primary Outcome Measure Information:
    Title
    Maintenance of Wakefulness Test (MWT)
    Description
    The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).
    Time Frame
    Change from baseline at 12 weeks or early termination
    Title
    Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit.
    Description
    Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
    Time Frame
    12 weeks or last post-baseline visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Diagnosis and Criteria for Inclusion: Patients are included in the study if all of the following criteria are met: Written informed consent is obtained. The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive). The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy. The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria. The patient meets the following nCPAP therapy requirements: Adequate education and intervention efforts to encourage nCPAP therapy use must be documented. A patient's nCPAP therapy regimen must be stable for at least 4 weeks. nCPAP therapy is shown to be effective, with effectiveness defined as having an apnea hypopnea index (AHI) of 10 or less during nocturnal PSG, and, in the opinion of the investigator, nCPAP is effective therapy. Following demonstration of effectiveness, evidence of regular nCPAP usage must be shown during a 2 week evaluation period (ie, nCPAP usage for at least 4 hours/night on at least 70% of the nights). The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology. Women must be surgically sterile, 2 years postmenopausal, or, if of child bearing potential, using a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study. The patient has a Clinical Global Impression of Severity of Illness (CGI S) rating of 4 or more. The patient has an ESS score of 10 or more. The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness. The patient is able to complete self rating scales and computer based testing. The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol. Criteria for Exclusion: Patients are excluded from participating in this study if 1 or more of the following criteria are met: has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) has a probable diagnosis of a current sleep disorder other than OSAHS consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day used any prescription drugs disallowed by the protocol or clinically significant use of over the counter (OTC) drugs within 14 days before the second screening visit has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM IV) has a positive urine drug screen (UDS) has a clinically significant deviation from normal in the physical examination is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) has used an investigational drug within 1 month before the initial screening visit has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) has a known clinically significant drug sensitivity to stimulants or modafinil

    12. IPD Sharing Statement

    Learn more about this trial

    Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome

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